FDA 21 CFR Part 11 Compliance

Regulatory agencies are now willing to accept paperless records but many producers in the food & beverage, pharmaceutical and biotech
industries haven’t yet converted or even planned to transition to paperless solutions.

Robust record keeping is at the heart of FDA 21 CFR Part 11 compliance and while the regulation itself does not require users to maintain
records electronically, the processing of data electronically has many advantages:

The utilization of the data by other systems: e.g. data viz applications, ERP systems, spreadsheets

The retrieval and comparison of several recording periods (not just the last 12 hrs) to observe trends that might otherwise be
overlooked between physical charts

Elimination of paper handling and the need to manage, store, or maintain large numbers of paper records

Clear and informative audit trails

Data backups and redundancy fail-safes

Define Instruments Cloud-based IIoT solutions provide a cost-effective way to store and harness your data digitally while complying
with the FDA’s criteria.

Achieve operational excellence with Define IIoT

Operational Oversight

Collect operational data from every machine for deeper insights into the workings of your business

Harness Meaningful data

Predict and Plan

With data insights you can achieve greater productivity, planning and growth.

Still using paper-based data recording?

Cloud-based IIoT data recording is now more economic and more flexible than paper record keeping, and the network infrastructure required
for data storage is significantly more accessible.

Additionally, compliance requirements such as restricted access for differing pay grades, password protection, digital signatures and data
backups are all now easily available within Define’s IIoT solution.

It’s time to do away with your ageing paper system and upgrade to a modern, user-friendly IIoT solution – a solution which provides so
much more than just the logging of data signals.